Tagged with Legal Handbook

Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? There are no legal documents in Vietnam providing a definition of “rare diseases.”   2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?) An orphan drug is a…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Law on Medical Examination and Treatment The draft version of an amended Law on Medical Examination and Treatment was submitted to the National Assembly in May 2022 for discussion. Once adopted, the new law will repeal the…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? PATENT To qualify for patent protection, an invention must meet the following basic conditions: Be globally novel; Involve an inventive step; and Have its subject matter capable of industrial application. TRADEMARK To be eligible for protection as a…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? The following types of liability are recognized under Vietnamese laws: disciplinary liability, administrative liability, civil liability and criminal liability.   2. How do these types of liabilities apply to the manufacturers of medicines and devices? Provisions on product liability can…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Law on Pharmacy and its implementing regulations are equally applicable to modern drugs and traditional and herbal drugs. There is no notion of alternative devices in Vietnamese law and therefore the legal framework for…

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? PHARMACEUTICAL PRODUCTS Under Vietnamese law, pharmaceutical products or drugs are defined to cover all modern drugs, herbal drugs, traditional drugs, vaccines, and biologicals. In general, a pharmaceutical product circulating…

Pharma Legal Handbook Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? By law, clinical research documentation for the purpose of obtaining the MA must conform to the guidance of the International Council for Harmonization (ICH), the MOH, or reference authorities recognized by Vietnam, including…

Pharma Legal Handbook What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Vietnam, pharmaceutical products (including drugs and biologicals) and medical devices are under the overall management of the Ministry of Health (www.moh.gov.vn). The Ministry of Health (“MOH”) is organized into a number of divisions,…

Pharma Legal Handbook The ins and outs of traditional medicines and OTC products in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.   1. What are the regulatory requirements…

Pharma Legal Handbook The key facts about regulatory reforms in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In Italy, the…

Pharma Legal Handbook The key facts about regulatory reforms in Italy. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. Are there proposals for reform or significant change to the healthcare system?…

Pharma Legal Handbook All legal aspects surrounding patents & trademarks in Italian Pharma. Prepared in association with Baker Mckenzie, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for GB 119.   1. What are the basic requirements to obtain patent and trademark…